(a) Identification. An apical closure device is a prescription device consisting of a delivery system and implant component that is used for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient contacting materials must be evaluated to be biocompatible.

(2) Performance data must validate the sterility of the patient-contacting components of the device.

(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(4) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Consistent and reliable implant deployment;

(ii) Assessment of implant pull-out force; and

(iii) Sheath size compatibility with implant.

(5) In vivo evaluation of the device must demonstrate device performance, including device operation resulting in closure of the myocardial wound.

(6) Labeling must include the following:

(i) Detailed information explaining how the device operates;

(ii) Sheath size that device can accommodate;

(iii) Identification of the minimum myocardial wall thickness to ensure optimal device function; and

(iv) A shelf life.

[81 FR 71371, Oct. 17, 2016]